Condition category
Infections and Infestations
Date applied
16/02/2006
Date assigned
16/03/2006
Last edited
20/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Reinaldo Menezes Martins

ORCID ID

Contact details

Av Brasil 4365
Rio de Janeiro
CEP 21040-900
Brazil
+55 21 3882 9479
rmenezes@bio.fiocruz.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ANVISA nr. 25351.086984/05-71

Study information

Scientific title

Acronym

Study hypothesis

The Brazilian vaccine is equivalent to Glaxosmithkline (GSK) vaccine.

Ethics approval

Ethics approval received from the National Ethics Committee of the Ministry of Health on the 24th May 2005 (ref: 11.501).

Study design

Double blind, randomised, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Diphtheria, tetanus, pertussis, haemophilus influenzae type B

Intervention

Three doses of Brazilian vaccines versus one dose of GSK vaccine

Intervention type

Drug

Phase

Not Specified

Drug names

Vaccine against diphtheria, tetanus, pertussis and haemophilus influenzae type B

Primary outcome measures

Polyribosil Ribitol Phosphate (PRP) titres and seroprotection after third dose should be equivalent to GSK vaccine.

Secondary outcome measures

1. Adverse event after each dose should be equivalent to GSK vaccine
2. Titres and seroprotection after second dose should be equivalent to GSK vaccine

Overall trial start date

03/01/2006

Overall trial end date

03/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy children from two to six months of age

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Unhealthy children
2. Previous vaccination
3. Immunodeficiency

Recruitment start date

03/01/2006

Recruitment end date

03/03/2007

Locations

Countries of recruitment

Brazil

Trial participating centre

Av Brasil 4365
Rio de Janeiro
CEP 21040-900
Brazil

Sponsor information

Organisation

Bio-Manguinhos/Fiocruz (Brazil)

Sponsor details

Av. Brasil 4365
Rio de Janeiro
CEP 21040-900
Brazil
+55 21 3882 9305
akira@bio.fiocruz.br

Sponsor type

Industry

Website

http://www.bio.fiocruz.br

Funders

Funder type

Industry

Funder name

Bio-Manguinhos/Fiocruz (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes